510(k) K233019

AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx by Hangzhou AllTest Biotech Co., Ltd. — Product Code DKZ

K233019 is an FDA 510(k) premarket notification submitted by Hangzhou AllTest Biotech Co., Ltd. for the device "AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx". The FDA issued a decision of Substantially Equivalent on December 13, 2023. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Hangzhou AllTest Biotech Co., Ltd. has at least 10 other 510(k) clearances on record.